GDP / Cold Chain GAP Audits

Regulators and customers are requesting documented evidence that the temperature sensitive products are being stored, handled and shipped within the temperature range specified on the label. PIC/s requires the manufacturer to be responsible for the life cycle of their product.

A cold chain audit from an operational perspective will identify gaps, non-conformance and potential high risks

GCCS can perform audits on-site together with the responsive person (RP) and process owners to identify gaps to mitigate risks.

All Audits are conducted following PIC/s, E.U. Good Distribution Practices (GDP) Guidelines & local regulations.03

GCCS have conducted extensive auditing for companies throughout the USA, Asia, the Middle East and Europe. Management are surprised at the large number of unidentified failures, gaps and critical excursions within companies supply chains as a result of the GCCS comprehensive auditing process.

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